Naval Medical Center San Diego
San Diego, California, 92134, United States
NCT Number: NCT07383584
This study will evaluate the impact of sleep banking on joint replacement surgery recovery.
Trial opening soon.
Get Notified18 year–74 year
All sexes
Interventional
Not applicable
San Diego, California, 92134, United States
Sleep is emerging as a target for pain management. The purpose of this study is to determine the feasibility and efficacy of extending sleep (sleep "banking") on self-reported pain outcomes post-surgery. This is a prospective, interventional, between-subjects, randomized study with a control condition. Participants will be patients undergoing knee or hip replacement surgery at Naval Medical Center San Diego. Participants will be randomized to either a sleep banking group, where they attempt to extend nightly sleep in the week leading up to surgery, or to a habitual sleep control group, sleeping in their typical pattern for that same period. Sleep and pain will be monitored daily yn the two weeks pre- and one week post-surgery. After that, they will be sent electronic follow-up sleep and pain questionnaires at 1, 3, 6, 9, and 12 weeks post-surgery. Participants in the sleep banking group will also complete additional questionnaire items on the feasibility and implementation of the sleep banking protocol. Feasibility of sleep banking will be assessed by examination of the sleep between groups during the intervention week, as well as by the analysis of the implementation questions. Efficacy will be assessed by examination of self-reported pain outcomes post-surgery by group. The primary hypothesis is that self-reported pain outcomes will be improved in the sleep banking group as compared to the control group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The sleep extension group will add 2 hour of sleep per night the week before surgery
Time frame: Weeks 1-15
Defense and Veterans Pain Rating Scale. On a scale of 0-10, with higher scores denoting more pain.
Time frame: Weeks 1-15
Opioid Use Diary
Time frame: Weeks 1-15
Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Physical Function subscale. Each item is scored on a scale 1-5, with 1=without any difficulty and 5=unable to do. Items will be summed and t-scored (0-100), with higher scores denoting less function.
Time frame: Weeks 1-15
Patient-Reported Outcomes Measurement Information System (PROMIS) -29 Adult Profile 2.0 Instrument, Sleep Disturbance subscale. Each item is scored on a scale 1-5, with 1=not at all and 5=very much. Items will be summed and t-scored (0-100), with higher scores denoting more sleep disturbance.
Contact information is provided by the study sponsor or research team.
Defense and Veterans Center for Integrative Pain Management
Other
Sleep Banking Pre-Surgery for Improved Chronic Post-Surgical Pain: A Pilot Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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